Status:
COMPLETED
Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy With HB110E
Lead Sponsor:
Genexine, Inc.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
20-60 years
Phase:
NA
Brief Summary
The purpose of this study is to examine the immunogenicity and efficacy of HBsAg Vaccine in combination with Entecavir in patients who have been treated with HB110E HBV DNA vaccine.
Eligibility Criteria
Inclusion
- subjects who have been treated with HB110E 2mg or 4mg within 6 months prior to screening.
- positive HBsAg at screening
- serum HBV DNA level below 300copies/mL at screening
- ALT level within 2 x ULN at screening
- voluntarily provide the informed consent
Exclusion
- participation in other study within 30 days of screening
- subjects with severe allergic reaction or severe adverse event to HBsAg vaccine, or not suitable for HBsAg vaccine.
- any other conditions that are considered inappropriate for the study by the investigator
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01813487
Start Date
February 1 2013
End Date
July 1 2013
Last Update
December 30 2013
Active Locations (1)
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1
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea, 137 701